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Association details:
| Biomarker: | PIK3CA mutation + HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | inavolisib (GDC-0077) (PIK3CA inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
To Evaluate the Safety, Tolerability, and Pharmacokinetics of GDC-0077 Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer
Excerpt:
...Locally advanced, recurrent, or metastatic, PIK3CA mutant, incurable solid tumor malignancy, including breast cancer...Postmenopausal female participants with locally advanced or metastatic PIK3CA-mutant HR+/HER2- breast cancer...Female participants with locally advanced or metastatic PIK3CA-mutant HR+/HER2- breast cancer...Female participants with locally advanced or metastatic PIK3CA-mutant HER2+ breast cancer...All participants must provide tumor tissue from the primary or metastatic tumor site obtained from a prior or new biopsy or surgical procedure for detection of PIK3CA mutation by central laboratory test...
Trial ID:
Source:
Title:
A phase I/Ib study of inavolisib (GDC-0077) in combination with fulvestrant in patients (pts) with PIK3CA-mutated hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer
Published date:
10/09/2021
Excerpt:
Data for inavolisib in combination with fulvestrant in female pts with PIK3CA-mutated, HR+/HER2- breast cancer (Arm D) are presented....Overall, 12/49 pts with measurable disease achieved a PR (25%; three of the responding pts had received prior fulvestrant; 11, prior CDK4/6i). Nine pts (18%) had a confirmed PR. CBR was 49% (27/55 pts). Preliminary median PFS was 7.1 months (0-29)....Inavolisib in combination with fulvestrant demonstrated a manageable safety profile, encouraging preliminary antitumor activity...
Secondary therapy:
fulvestrant
Trial ID:
Source:
Title:
Abstract CT109: A phase I/Ib study evaluating GDC-0077 plus fulvestrant in patients with PIK3CA-mutant, hormone receptor-positive/HER2-negative breast cancer
Published date:
04/27/2020
Excerpt:
...we present data of G + fulvestrant (F) in postmenopausal patients (pts) with PIK3CA-mutant, hormone receptor-positive/HER2-negative BC...Overall, 5/14 pts with measurable disease had a PR (36%; 2 received prior F; 4, prior CDK4/6i), of whom 2 pts (14%) had a confirmed PR. CBR was 60% (12/20 pts). Most pts showed decreased ctDNA PIK3CA-mutant allele frequency during treatment. Conclusion: G + F demonstrated a manageable safety profile, similar PK to G alone, preliminary antitumor activity, and PD modulation of PIK3CA-mutant allele frequency in ctDNA.
Secondary therapy:
fulvestrant
DOI:
10.1158/1538-7445.AM2020-CT109
Trial ID:
